What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments

Tanya R. Schlam, Timothy B. Baker, Megan E. Piper, Jessica W. Cook, Stevens S. Smith, Deejay Zwaga, Douglas E. Jorenby, Daniel Almirall, Daniel M. Bolt, Linda M. Collins, Robin Mermelstein, Michael C. Fiore

Research output: Contribution to journalArticlepeer-review


Aim: To compare effects of three post-relapse interventions on smoking abstinence. Design: Sequential three-phase multiple assignment randomized trial (SMART). Setting: Eighteen Wisconsin, USA, primary care clinics. Participants: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. Interventions: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini-lozenges + encouragement to quit starting 1 month post-randomization (preparation); (2) repeated encouragement to quit starting immediately post-randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini-lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. Measurements: The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7-day point-prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. Findings: Neither skill training nor supportive counseling (each on versus off) increased 14-month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14-month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = −1.8−5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5–6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7–8.9%, OR = 3.5, 95% CI = 1.0–12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. Conclusions: Among people interested in quitting smoking, immediate encouragement post-relapse to enter a new round of smoking cessation treatment (‘recycling’) produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re-engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy.

Original languageEnglish (US)
Pages (from-to)898-914
Number of pages17
Issue number5
StatePublished - May 2024


  • Chronic care smoking treatment
  • factorial experiment
  • nicotine replacement therapy
  • phase-based model of smoking treatment
  • primary care
  • relapse
  • sequential multiple assignment randomized trial (SMART)
  • smoking cessation
  • tobacco dependence

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Psychiatry and Mental health


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